FDA-Device2024-04-03Class II
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Puritan Medical Products Company, Llc
Hazard
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Sold states
Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IA, ID, IL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, OK, PA, TX, VA and the countries of Canada, P.R. China and Thailand.
Affected count
465 boxes x 500 units per box = 232,500 units
Manufactured in
31 School St, N/A, Guilford, ME, United States
Products
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief